Events

Recall of BECKMAN COULTER AU 5400 IMMUNOCHEM SYS - RHEUMATOID FACTOR (RF) LATEX ASSY

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BECKMAN COULTER CANADA L.P..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    50405
  • Event Risk Class
    III
  • Event Initiated Date
    2012-07-26
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    A discrepancy was observed whereby the reagent on-board stability on the parameter setting sheets stated 90 days and the ifu states 60 days. while in-house studies have shown that the product is stable on-board for 90 days the 60 day stability claim will remain so that the parameter setting sheets ifu and regulatory documentation are aligned.

Device

BECKMAN COULTER AU 5400 IMMUNOCHEM SYS - RHEUMATOID FACTOR (RF) LATEX ASSY
  • Model / Serial
    Model Catalog: OSR61105 (Lot serial: ALL)
  • Product Description
    RF LATEX ASSAY (ON AU5400)
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.